تاریخ بروزرسانی: 4 دسامبر 2024 ساعت 03:20
Table of Contents
Part I- An Introduction to Health Law 15
Introduction to the first Part 16
Chapter One – Introduction to Law 17
Section 1- Definition & Historical Background 18
1-1- Definition 18
1-2- Historical Background 18
Section 2 – Legal Terminology 20
2-1- Genral Terminology 20
2-2- Specialized Terminology 25
Section 3 – State & Government 26
3-1- State 26
3-2- Government & Duties of the Triple Powers 27
Section 4 – Sources & Classifications of law / Legal Systems 35
4-1- Sources of Law 35
Section 5 – Divisions of Law 38
5-1- Private law 38
5-2- Public Law 38
5-3- Difference Between Private Law and Public Law 41
Section 6 – Administrative Law 42
6-1- Definition & Historical Background 43
6-2- Principles of Administrative Law 45
6-3- Powers of Administrative Agencies 48
6-4- Integrity & Corruption in Bureaucratic System 52
6-5- Administrative Hearing 56
Chapter Two – An Introduction to Health Law 59
Section 1- Medical Law as a Branch of Health law 60
1-1- Definition 60
1-2- Historical Back Ground 60
1-3- Differences Between Medical Law & Health Law 60
Section 2 – Branches 62
2-1- Classic and Modern 62
2-2- Thematic & Transversal 62
Section 3- Approaches / Components 63
3-1- Right to health as a Human Right 63
3-2- Public Health Law 63
3-3- Health Care Law 64
3-4- Bioethics 64
Section 4 – Levels of Health Law 66
4-1- National 66
4-2- International 66
4-3- Comparative 66
Section 5 – Sources of Health Law 67
5-1- Main Divisions 67
5-2- Subdivisions 67
Chapter Three – Health Policy-making 69
Section 1- Policy as a Tool 70
1-1- Regulatory tools 70
1-2- Allocative tools 70
Section 2- Requirements & Priorities 71
2-1- Application of Analytical Tools 71
2-2- Lobbying 71
Chapter Four –Good Governance in Health (G.G.H.) 73
Section 1 – Definition and Historical Background 74
1-1- Definition 74
1-2- Historical Background 74
Section 2 – Principles of Good Governance 76
2-1- Transparency 76
2-2- Rule of Law 77
2-3-Participation 77
2-4- Accountability 77
2-5- Equity 77
2-6- Efficiency 77
2-7- Responsibility 78
2-8- Sustainability 78
Section 3 – Principles of Good Governance for Health (G.G.H) 79
3-1- Strategic Vision 79
3-2- Participation 79
3-3- Rule of Law 79
3-4- Transparency 79
3-5- Accountability 79
3-6- Equity 79
3-7-Effectiveness 79
3-8- Responsibility 80
3-9- Intelligence and Information 80
3-10- Ethics 80
Section 4 – Principles of Good Governance for Medicine (G.G.M) 81
4-1- Manufacturing 81
4-2- Registration 81
4-3- Selection 82
4-4- Procurement 82
4-5- Distribution 82
4-6- Prescription 82
Part II – Human Rights & Right to Health 83
Introduction to Part Two 84
Chapter One – Introduction to Human rights & Right to Health 85
Section 1- Human rights 86
1-1- Definition 86
1-2- Characteristics 86
1-3- Dimensions 87
Section 2- Right to health 88
2-1- Definition 88
2-2- Historical Background 88
Section 3 – International Documents 89
3-1- Universal Declaration of Human Rights, Article 25 90
3-2- Constitution of WHO 90
3-3- International Convention on Economic, Social and Cultural Rights 90
Chapter Two – Elements of Right to Health 91
Section 1- Availability 92
1-1- Facilities and Equipments 92
1-2- Human Resources 92
Section 2 – Accessibility 93
2-1- Non-Discrimination 93
2-2- Physical Accessibility 93
2-3- Economic Accessibility 93
2-4- Information Accessibility 93
Section 3 – Acceptability 95
3-1- Respect to Beliefs 95
3-2- Privacy and Confidentiality 95
Section 4 – Quality 96
4-1- Standardisation 96
4-2- Licensing 96
Chapter Three – States’ Commitments and easures 97
Section 1- Commitments 98
1-1- Commitment to Respect 98
1-2- Commitment to Protect 98
1-3- Commitment to Fulfill 99
Section 2 – Measures 100
2-1- Legislative Measures 100
2-2- Judicial and Quasi-Judicial Measures 100
2-3- Executive and Administrative Measures 101
Part III – Public Health Law 103
Introduction to Part Three 104
Chapter One – An Introduction to Public Health Law 105
Section 1- Definition 106
Section 2- Historical Background 107
Section 3- Characteristics 108
3-1- Role of State 108
3-2- Populations 108
3-3- Relationship 108
3-4- Services 108
3-5- Coersion 108
Chapter two – International Health law 109
Section 1- Definition & Historical Background 110
Section 2- Sources of International Law 112
2-1- Treaties/ conventions 112
2-2- Customary International Law 112
2-3- General Legal Principles 112
2-4- Judicial verdicts/ case law 112
2-5- Soft Law & Hard law 112
Section 3 – International Organizations Related to Global Health Governance 113
Section 4 – Global Health Issues 114
4-1- Regulation on Health Research 114
4-2- Regulation on International Travels 114
4-3- Intellectual Property Rights and International Health 114
Section 5 – Public Health & Administrative Law 116
5-1- Duties of Regulatory Agencies 116
5-2- Public Health Through Rulmaking 116
5-3- Supervision on Good Enforcement of Laws 117
Section 6- Administrative Law’s Tools for Public Health 119
6-1- Licenseing 119
6-2- Inspection 119
6-3- Enforcing Legal Powers for Public Health 119
Chapter Three – Health Economic Policy and Law 121
Section 1- The Role of World Trade Organization (WTO) 122
1-1- Historical Background 122
1-2- Important International Agreements 122
Section 2- Health insurance 123
2-1- Types 123
2-2- Coverage 123
Secction 3 – Fraud and Abuse 124
3-1- Instances 124
3-2- Laws 124
Section 4 – Intellectual Property Rights (IPRs) 125
4-1- Elements 125
4-2- Aims 125
Section 5 – Antitrust 126
5-1- Goals of Antitrust Law 126
5-2- Important Acts 126
Section 6 – Tax 127
6-1- Financial Procurements 127
6-2- Tax Exemptions 127
Chapter Four- Transmissible Diseases 129
Section 1- International Health Regulations (IHR) 130
1-1- Subjectives 130
1-2- State’s Obligations 131
Section 2- Transmissible Diseases Prevention 132
2-1- Vaccination 132
2-2- Isolation and Quarantine 132
2-3- Criminal Liability 132
Section 3 – Discovery and Reporting Disease 134
3-1-Discovery 134
3-2- Reporting 134
Section 4 – Privacy and Confidentiality 136
4-1- Privacy 136
4-2- Confidentiality 137
Chapter Five – Bioterrorism 139
Section 1- Definition & Historical Background 140
Section 2- Legal Measures 141
2-1- Role of Laws and Regulations 141
2-2- Legal Punishments 141
Section 3 – International Treaties 142
3-1- Geneva Protocol (1925) 142
3-2- Biological Weapons Convention (1925) 142
Chapter Six- Environmental Health Law 143
Section 1- International Conventions/ Agreements 144
1-1- Stockholm Convention on Persistent Organic Pollutants. 144
1-2- The UN Framework Convention on Climate Change 144
Section 2 – U.S.A Acts 146
2-1- Environmental Protection Act (1990) 146
2-2- Clean Air Act (1993) 146
2-3- Clean Water Act/ Water Pollution Control Act 1971 146
2-4- Safe Drinking Water 1974 147
Chapter Seven- Food Law 149
Section 1- Counterfeit Foods 150
1-1- Labeling Requirements 150
1-2- Advertisement Regulation 150
Section 2 – Product Liability 151
2-1- Liability 151
2-2- Compensation 151
Chapter Eight- Pharmaceutical Law 153
Section 1- Pre-Market & post-market Requirements 154
1-1- Marketing Authorization 154
1-2- Labeling 154
1-3- Advertising 155
1-4- Pricing 155
Section 2 – Liability 156
2-1- Civil Liability Vs. Criminal Liability 156
2-2- Corporate Liability Vs. Individual Liability 156
2-3- Contractual Liability Vs. Non-contractual Liability 156
Section 3 – Diffrent Actions 157
3-1- Product Liability Claim 157
3-2- Strict Liability Claim 157
3-3- Fraud and Mispresentation Claim 157
3-4- Negligence Claim 157
3-5- Breaching Patent Claim 157
3-6- Claim for Breaching Antitrust Act 158
Chapter Nine – Occupational Safety and Health Law(OSHS) 161
Section 1- International OSHL 162
1-1- Historical Background 162
1-2- objectives 162
Section 2 – Occupational Health Professionals Duties 163
2-1- Employment Protection 163
2-2- Providing Health Care Services 163
Section 3 – Employers Duties 165
3-1- Compensation 165
3-2- Medical Tests 165
Chapter Ten- Mental Health Law 167
Section 1- Alternative Decision Making 168
1-1- Selecting Alternative Models 168
1-2- Individual Interests 169
Section 2- Admission and Leaving Hospital 170
2-1- Admission Requirements 170
2-2- Voluntary Admission 170
2-3- Compulsory Admission 170
2-4- Discharge 171
Section 3 – Criminal Justice 172
3-1- Insanity Defence 172
3-2- Limited Liability 172
Chapter Eleven- Vulnerable Populations and Health Law 175
Section 1- Women Health Law 176
1-1- Sexual and Reproductive Health 176
1-2- Occupational Health 178
1-3- Discrimination and Violence Against Women 178
Section 2 – Disability Health Law 180
2-1- Special Protection for Disabled Children 180
2-2- Protection from Discrimination 181
2-3- Protection from Mistreatment 182
Section 3 – Elder Health Law 184
3-1- Competency 184
3-2- Informed Consent 184
3-3- Elder Abuse & Mistreatment 185
Section 4 – Children Health Law 187
4-1- Informed Consent 187
4-2- Child Abuse & Mistreatment 188
Part IV – Health Care Law 191
Introduction to Part Four 192
Chapter One – An Introduction to Health Care Law 193
Section 1- Definition & Historical Background 194
1-1- Definition 194
1-2- Historical Background 194
Section 2 – Theories Governing Health Care Law 195
2-1- Utilitarianism 195
2-2- Deontology 195
2-3- Consequentialism 195
Section 3 – Ethical Principles 196
3-1- Autonomy 196
3-2- Beneficence 196
3-3- Non-maleficence 196
3-4- Justice 196
Section 4 – Type of Commitments & Liabilities 197
4-1- Ethical and Religious 197
4-2- Liability 197
4-3- Disciplinary/ Administrative Liability 199
Chapter Two – Tort & Negligence 201
Section 1- Types 202
Section 2 – Elements of Tort 203
2-1- Duty of Care 203
2-2- Breach of Duty 203
2-3- Damage 203
2-4- Causation 203
Section 3 – Strategies Against Negligence Liability 205
3-1- Obtaining Informed Consent 205
3-2- Maintaining Privacy and Confidentiality 205
3-3- Regulation of Health Care Professionals 205
3-4- Civil Liability Insurance/ Professional Liability Insurance 206
Chapter Three – Informed Consent 209
Section 1- Types of Consent 210
1-1- Expressed Consent 210
1-2- Implied Consent 210
Section 2- Elements of Informed Consent 211
2-1- Competency 211
2-2- Informed Decision 211
2-3- Freely Make Decision 212
Chapter Four- Privacy and Confidentiality 213
Section 1- Related Laws 214
1-1- Contract law 214
1-2- Tort Law 214
1-3- Property Law 214
1-4- Criminal Law 214
Section 2 – Liability of Breaching Confidentiality 215
2-1- Civil Liability 215
2-2- Criminal Liability 215
Section 3 – Legal Exceptions 216
3-1- Consent for disclosure 216
3-2- Public Health Benefits/ Interests 216
3-3- Serious Damage Risk 216
3-4- Police Investigations 216
Chapter Five – Electronic Health Law 217
Section 1- Legal Challenges of Telemedicine 218
1-1- Privacy & Confidentiality 218
1-2- Licensing 218
1-3- Jurisdiction and Governing Laws 219
1-4- Corporate Liability 219
1-5- Insurance & Compensation 220
Section 2 – Types of Internet Pharmacies and Legal Challenges 221
2-1-Types 221
2-2- Challenges 221
Chater Six- Complementary and Alternative Medicine (CAM) 223
Section 1 – Ethical Issues 224
1-1- Patient’s Autonomy for Consent 224
1-2- Principle of Beneficence & Non-maleficence 224
1-3- Professional-Patients Relationship 225
1-4- Equity 225
Section 2 – Licensing 226
2-1- License for Professionals 226
2-2- License for Products 226
Section 3 – Liabilities 228
3-1- Malpractice / Negligence Liability 228
3-2- Referral Liability 228
3-3- Fraud and Mispresentation Liability 229
Part V – Bioethic 231
Introduction to Part Five 233
Chapter One – An Introduction to Bioethics 235
Section 1- Concepts and Definitions 236
1-1- Ethics 236
1-2- Difference Between Ethics and Moral 236
1-3- Difference Between Ethics and Law 236
1-4- Relationship Between Ethics, Law and Medicine 237
1-5- Ethic Codes 237
Section 2 – Bioethics 238
2-1- Definition 238
2-2- Historical Background 238
Section 3 – Domain & Sources 240
3-1- Domain 240
3-2- Sources 240
Chapter Two – Assisted Reproductive Technologies (ART) 241
Section 1- Types / Classification 242
1-1- Artificial Insemination 242
1-2- In Vitro Fertilization 242
1-3- Cloning 242
Section 2 – Sexual and Reproductive Health 243
2-1- Definition 243
2-2- Dimensions 243
Section 3 – Sexual and Reproductive Rights 244
3-1- Related Rights 244
3-2- Religious and Ethical Issues 244
Chapter Three – Clinical Trial/ Medical Research 247
Section 1 – Ethics and Regulation on Clinical Trials 248
1-1- Commitment to Protect Subjects 248
1-2- Supervision and Liability 249
Section 2 – Informed Consent 250
2-1- Competent Adults 250
2-2- Incompetent Adults 250
Section 3 – Research Negligence/ Malpractice 252
3-1- Elements of Malpractice & Negligence 252
3-2- Criminal Offences 252
Chapter Four- Abortion 253
Section 1 – Types / Classifications 254
1-1- Therapeutic Abortion 254
1-2- Criminal Abortion 255
Section 2 – Religious View on Abortion 256
2-1- Religious View on the Therapeutic Abortion 256
2-2- Religious View on Nontherapeutic Abortion 256
Section 3 – Ethical & Legal Status of Fetus 258
3-1- Ethical Status 258
3-2- Legal Status 258
Section 4 – Reasons for and Against Legalization 259
4-1- Reasons For 259
4-2- Reasons Against 259
Section 5 – Legal Considerations 260
5-1- Serious Risks 260
5-2- Informed Consent 260
Chapter Five- Euthanasia 261
Section 1 – Types / Classifications 262
1-1- Based on Consent 262
1-2- Based on Direct and Indirect Effect 262
Section 2 – Traditional Debates 264
2-1- Sanctity of Human Life 264
2-2- Value of Human Life 264
2-3- Quality of Human Life 265
Section 3 – Reasons for and Against Euthanasia 266
3-1- Reasons Against 266
3-2- Reasons For 267
Section 4 – Debates on Physician assisted Suicide 268
4-1- Palliative Care 268
4-2- Doctrine of Double Effect 268
Section 5 – Different Views on Suicide and Euthanasia 269
5-1- Islam 269
5-2- Judaism and Christianity 269
5-3- Buddhism 269
5-4- Hinduism 269
Chapter Six- Organ Donation and Transplantation 271
Section 1 – Types of Donation 272
1-1- Living Donation 272
1-2- Cadaveric Donation 273
1-3- Xenoplantation 275
Section 2 – Strategies for Increasing Organ Donation 277
2-1- Opt Out Plan 277
2-2- Opt in Plan 278
2-3- Market for Organ Donation 278
2-4- Transplant Tourism 279
Chapter Seven- Human Genetic 281
Section 1 – Genetic Screening 282
1-1- Purposes 282
1-2- Positive and Negative Effects of Prenatal Screening 282
Section 2 – Ethical, Legal and Social Concerns 283
2-1- Genetic Discrimination 283
2-2- Privacy and confidentiality 284
Section 3 – Genetic Counseling 285
3-1- Patient- health care professional Relationship 285
3-2- Informed Consent 285
Section 4 – Genetic Engineering 287
4-1- Religious Approach 287
4-2- Ethical Issues 287
Foreword
The huge tree of knowledge is flourishing increasingly, and new branches are added to it every day. Some of these branches are connected to each other to shape interdisciplinary sciences that the link between Law and different industries including health care industry is the most important ones.Furthermore, factors such as the new phenomenon of globalization, increase international commercial relationships, facilitation and increase international travels, common global problems in environmental issues, spread of transmissible diseases and requiring unified global suggestions, criterions and standards have made this link stronger.
“Health law” is an interdisciplinary field which has been separated from main body of medical law during recent decades. It is more extensive and comprehensive than medical law and includes issues such as new environmental, economic and health challenges, it should be considered as a gigantic child of medical law. Health law is more extensive than medical law. in moreover, the physician is out of focus and is not solely addressed in acts and regulations and a group of professionals named as health care professionals including dentists, nurses, radiologists, surgeons. have liabilities for caring patients’ health and must consider professional standards in order to prevent negligence and malpractice.
In this research work, health law is categorized based on four approaches including Right to Health; public and population dimensions (public health law) ethical issues (bioethics), individual dimensions with focus on liability (health care law), although, some sources have considered health law synonymous to health care law and also have presented an amalgam of these areas in a unified format named as health care law.
In this collection, health law, ha been prepared in four respective chapters under the titles of health law; human rights and health law, public health law, bioethics and health care law, considering the table of the contents and titles of hundreds of valid books and articles in this area. Health care law has a particular legal position as an approach based on individual rights and professionals’ liabilities and meanwhile is originated from macro policies of public health law. Bioethics as the ethical dimention of health law is investigated in the last chapter. Legal and ethical issues and challenges are somehow solvable relying on acts and regulations that are appropriate to the conditions of the day and with a glance to every community’s cultural background; so addressing these issues can be helpful for legislators in updating acts and regulations.
Anyway, despite defects caused by human effects, this compilation has done its best to present a definite and well founded framework of health law regarding standards of compilation appropriateness in order to enable the honorable readers to follow their expected issues in the format of chapters, subjects, parts and even sub-parts easily.
Hope that honorable readers help us in making this better in the future editions by their valuable guidelines and provide the context for future success in vital area of health.
Dr. Shahriar Eslamitabar (DMD, Ph.D.)
Spring, 2022
Publisher Preface
From the first humans up to now, considering different human rights areas such as fundamental human rights have led to human civilization and development. Meanwhile, the role of health and health law is of great importance. It is not possible to achieve a dynamic, efficient and happy community without health, so the necessity of linkage between these important issues in the format of health law is felt completely.
Health law is a relatively new field that its extensiveness and vital importance is more than medical law and is originated from human fundamental rights (the right to health); considering it and its vital dimensions such as environmental health is mandatory for constant growth and development. Because of this it is seriously followed in developmental scientific plans in national and international social sector by states and international bodies particularly World Health Organization (WHO), in addition to being placed in theoretical framework of law sciences.
Studying health law has several benefits that will guide the community in line with different dimensions of prosperity and will be a great help in citizens’ physical and mental health and safety. This important issue will be possible through presenting information about the developments ways for health national plans, helping research and development, making domestic laws and regulations close to international rules, helping judges to issuing verdicts for such cases and making important and vital decisions related to citizens’ right to health in national and international arena. Therefore, this collection will be helpful for educators, students, scholars, country’s macro politician, legislators and judges in medicine and health area.
All human rights dementions, including social, cultural and economic rights which have been less controversial than civil and political rights for states and people, has always been protected by policies or legal frameworks enforced by regulations in order to realize citizens’ rights.
Dear Dr. Shahriar Eslamitabar having more than 25 years’ experience in teaching and research in public, health and administrative law and being in management positions, has presented a unique collection for all scholars, judges, executive managers, legislators and politicians of this area and particularly students of medicine and law, by compiling this relatively comprehensive collection using several valid international sources.
In addition to increasing awareness of the officials and health practitioners about legal and ethical issues, this collection can provide the ground for scientific enhancement and health law development at the country level. Regarding the national and international importance of health law as a relatively new comprehensive interdisciplinary area and the lack of a unified work that has been compiled and translated from several valid foreign sources by an outstanding expert, requirement of such a work in the country was felt